We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare (WeCAB)

Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care

The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care.

The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation.

Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women; Maternal Health
• Intervention / Treatment: Behavioral: WeCAB Intervention

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aimee Afable, PHD; Phone Number: 718-270-6397; Email: aimee.afable@downstate.edu
• Study Contact Backup: Name: Sandra Bruening, MS; Phone Number: 518-217-2531; Email: sandra.bruening@downstate.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • University Hospital at Downstate
      • Contact: Steven Levine, MD; Phone Number: 718-270-3188; Email: steven.levine@downstate.edu
      • Contact: Nadege Gilles, MPH; Phone Number: 718-270-7786; Email: nadege.gilles@downstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible participants for the pilot RCT will be patients
• aged 18-49 years (childbearing age)
• residing in a Central Brooklyn zip code
• self-reporting as Black,
• who speak English or Haitian Creole, and
• plan to deliver or present for delivery at University Hospital at Downstate (UHD).
• In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline.

Exclusion Criteria:

• Patients planning to move outside of New York City in the ensuing 3 months post-partum
• Patients demonstrating an impairment that limits their ability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: WeCAB Intervention	Behavioral: WeCAB Intervention; The WeCAB intervention will use a dedicated WeCAB community health worker who will administer a social determinants of health (SDOH) tool and use digital care navigation to monitor closed loop referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of postpartum care	Initiation of postpartum care within 6 weeks of delivery	13 weeks until 3 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal death	Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.	13 weeks until 3 weeks postpartum

Collaborators and Investigators

• Sponsor: State University of New York - Downstate Medical Center
• Investigators: Principal Investigator: Aimee Afable, PHD, SUNY Downstate

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Digital
• Other Study ID Numbers: 1R21NR020706-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No